Actively Recruiting
A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Led by University of Illinois at Chicago · Updated on 2026-01-08
36
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II study to assess the efficacy, safety, and Health Related Quality of Life (HRQoL) of combination cabozantinib and pembrolizumab as maintenance therapy for patients with metastatic squamous Non Small Cell Lung Cancer(sqNSCLC) who have received 4 cycles of induction therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel.
CONDITIONS
Official Title
A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization.
- Age 18 years or older.
- ECOG Performance Status of 0, 1, or 2 within 28 days before registration.
- Life expectancy of 6 months or more.
- Histologically or cytologically confirmed squamous non-small cell lung cancer.
- Stage IV NSCLC without prior therapy for metastatic disease or locally advanced/recurrent disease eligible for first-line induction.
- Disease control (complete response, partial response, or stable disease) after induction therapy.
- Tumors tested for PD-L1 expression.
- Adequate organ function based on specific laboratory values within 14 days prior to registration.
- Recovery to baseline or Grade 1 or less from prior treatment toxicities.
- Use of medically accepted contraception during study and for 4 months after last dose.
- Negative pregnancy test for females of childbearing potential and no pregnancy.
- Ability to understand and comply with study requirements and sign informed consent.
- Willingness and ability to follow scheduled visits, treatments, and tests.
You will not qualify if you...
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding.
- Previous treatment with cabozantinib.
- Use of small molecule kinase inhibitors within 2 weeks before study treatment.
- Use of cytotoxic, biologic, or other systemic anticancer therapy within 4 weeks before study treatment.
- Radiation therapy to bone metastasis within 2 weeks or other radiation within 4 weeks before treatment.
- Evidence of major blood vessel invasion or encasement by cancer.
- Central cavitating lung lesions or endobronchial disease; peripheral cavitary lesions allowed only if resolved after induction.
- Presence of targetable genomic mutations with approved therapies.
- Uncontrolled significant illness including serious heart conditions, uncontrolled hypertension, recent stroke or thromboembolic events.
- Gastrointestinal disorders with high risk of perforation or fistula, recent abdominal complications.
- Serious non-healing wounds, malabsorption, hypothyroidism, severe liver impairment, or dialysis requirement.
- Recent use of systemic steroids or immunosuppressive therapy beyond allowed exceptions.
- Significant bleeding history within 12 weeks before treatment.
- Untreated or unstable brain metastases.
- Use of certain anticoagulants except allowed low-dose aspirin or stable low molecular weight heparin.
- Live vaccine within 30 days before treatment.
- Active or history of autoimmune or immune deficiency diseases, certain infections.
- Allergy to study drugs or severe infusion reactions.
- Other active malignancies requiring treatment except certain cured cancers.
- Recent major or minor surgery without complete healing.
- Previous organ or stem cell transplant.
- Inability to swallow tablets or receive IV treatment.
- Prolonged QT interval on ECG.
- Other severe medical or psychiatric conditions or inability to consent or comply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ryan Nguyen
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Ryan Nguyen, DO
CONTACT
R
Ruihong Yin, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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